Senior Manager, Quality Control GMP

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Quality Control GMP based in the United States. This role provides senior-level scientific and technical leadership across Quality Control activities supporting clinical and commercial manufacturing programs. You will act as a key QC subject-matter expert for drug substance and drug product testing, method lifecycle management, and GMP compliance. The position offers broad cross-functional exposure, partnering with CMC, Analytical Development, Manufacturing, Quality Assurance, and external laboratories. You will help ensure reliable release and stability testing strategies while supporting complex investigations and regulatory requirements. As a senior individual contributor, you will influence technical decisions, solve complex quality challenges, and drive continuous improvement. The role also provides opportunities to mentor colleagues and contribute to the development of robust, compliant QC operations.

As a senior QC technical leader, you will oversee critical analytical and GMP activities while partnering with internal teams and external manufacturing and testing organizations. You will contribute to both operational execution and strategic quality initiatives across the product lifecycle. Provide scientific leadership for QC GMP activities, including analytical method transfer, qualification, validation, and lifecycle management for drug substance and drug product. Serve as a QC subject-matter expert for release and stability testing, including data review, trending, interpretation, and assessment. Lead or support investigations involving deviations, out-of-specification (OOS), and out-of-trend (OOT) results, including root cause analysis and CAPA development. Partner with Analytical Development and CMC teams to facilitate successful method transfers to QC laboratories and external contract manufacturing organizations. Oversee QC activities performed by contract testing laboratories and manufacturing partners, including data package review and compliance with quality and regulatory expectations. Contribute to the development and execution of control strategies for small-molecule drug substance and drug product. Author, review, and approve QC documentation, including analytical methods, specifications, protocols, validation reports, and regulatory submission materials. Support regulatory inspections and quality audits through preparation, response, and follow-up activities. Identify and implement opportunities to improve QC processes, technologies, efficiency, and compliance practices. Mentor junior team members and act as a technical resource across cross-functional teams. Requirements: The ideal candidate brings substantial experience in pharmaceutical Quality Control or analytical sciences, strong knowledge of GMP requirements, and the ability to independently lead complex technical initiatives. You should be comfortable influencing stakeholders, managing external partners, and communicating analytical concepts clearly in a regulated environment. Ph.D. in Chemistry, Pharmaceutical Sciences, or a related discipline with significant QC or analytical sciences experience in a GMP environment, or an M.S./B.S. with substantial relevant industry experience. 5–8 years of experience in QC testing and GMP compliance supporting clinical and/or commercial-stage pharmaceutical programs. Strong expertise in analytical techniques used for small-molecule pharmaceuticals, including HPLC/UPLC, GC, dissolution, spectroscopic methods, and wet chemistry. Deep understanding of analytical method validation, transfer, qualification, and lifecycle management within regulated environments. Demonstrated experience leading or supporting deviation, OOS, and OOT investigations and CAPA processes. Working knowledge of global regulatory requirements, including FDA, EMA, ICH guidelines, and compendial standards such as USP and EP. Experience managing or overseeing external laboratories, CMOs, or CROs. Ability to work independently, manage multiple priorities, solve complex problems, and influence cross-functional stakeholders. Strong written and verbal communication skills, with the ability to explain technical concepts and analytical data clearly. Benefits: Salary range of $155,000–$185,000 USD. Target bonus of 15%. Ongoing stock awards. 100% company-paid medical, dental, and vision premiums for employees and their families. Company funding of up to 75% of in-network deductibles to help reduce out-of-pocket healthcare costs. 401(k) matching with immediate vesting. Generous paid time off. 12 weeks of fully paid parental leave. Paid family and medical leave for all employees, regardless of location. Company-paid short-term disability coverage for up to 20 weeks. Wellness programs and tuition reimbursement. Inclusive family-forming support. Remote position within the United States.

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